Senior Scientist, Small Molecule Analytics & CMC Lead

Glaukos Corporation; Aliso Viejo (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Glaukos Corporation seeks a senior analytical development lead to shape, validate, and transfer analytical methods for small and large molecule drug development from early clinical to commercialization. You will oversee stability studies and provide regulatory-ready data for submissions, collaborating with CROs/CMOs and representing the analytical function on CMC teams.

The role requires a PhD or MS with extensive industry experience in analytical development and strong GMP/ICH/FDA standards

Qualifications

• PhD (3+ years) or MS (8+ years) in pharmaceutical or analytical sciences.
• 3+ years industry experience in analytical development.
• Strong expertise in chromatographic and spectrometric techniques (HPLC, UPLC, GC, LC-MS, UV/Vis).
• Experience with GMP, ICH, FDA standards.
• Proven method development, validation, transfer, and stability oversight skills.

Responsibilities

• Design, validate, transfer analytical methods.
• Oversee stability studies and trending analysis.
• Collaborate with CROs and CMOs.
• Prepare regulatory documentation.
• Represent as analytical lead on CMC teams.
• Troubleshoot technical challenges.
• Evaluate data for regulatory submissions.
• Innovate with new assay technologies.

Skills

Analytical development

Method transfer

Troubleshooting

Regulatory data review

Education

PhD in pharmaceutical/analytical sciences

MS in pharmaceutical/analytical sciences

Tools

HPLC

UPLC

GC

LC-MS

UV/Vis

Job description

Glaukos Corporation seeks a senior analytical development lead to shape, validate, and transfer analytical methods for small and large molecule drug development from early clinical to commercialization. You will oversee stability studies and provide regulatory-ready data for submissions, collaborating with CROs/CMOs and representing the analytical function on CMC teams.

The role requires a PhD or MS with extensive industry experience in analytical development and strong GMP/ICH/FDA standards